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NCT Number: NCT05932303

A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants

This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.

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Key information

Conditions

Healthy Participants Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Québec, CA, G1P 0A2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) through 32.0 kg/m^2, inclusive.

BMI = weight (kg)/(height [m])2.

  • Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion criteria

  • Any significant acute or chronic medical illness.
  • Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
  • Any major surgery within 4 weeks of study intervention administration.

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

Itraconazole

Drug

Specified dose on specified days

Gemfibrozil

Drug

Specified dose on specified days

carbamazepine

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 33 days

  2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])

    Time frame: Up to 33 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

    Time frame: Up to 33 days

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 33 days

  2. Number of participants with physical examination abnormalities

    Time frame: Up to 33 days

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 33 days

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 33 days

  5. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 33 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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